Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121875
Status:
TERMINATED
Last Update Posted:
2009-09-29
First Post:
2005-07-14
Brief Title:
Study to Identify Markers of Insulin Resistance During Growth Hormone Treatment for Short Stature
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Growth Hormone and Insulin Resistance in Girls With Turner Syndrome or Idiopathic Short Stature
Status:
TERMINATED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was too low
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Growth hormone treatment improves body fat distribution but also causes insulin resistance Scientists have recently linked insulin resistance with special stores of fat in the muscles which can be measured by magnetic resonance imaging MRI The researchers hypothesize that growth hormone will paradoxically reverse the linkage between muscle fat stores and insulin resistance To assess this association and to investigate the causes the researchers will measure muscle fat stores during growth hormone treatment Other parameters linked to insulin resistance glucose tolerance blood markers and body composition will also be assessed This study may lead to improved strategies for monitoring growth hormone therapy
Detailed Description:
Growth hormone GH treatment can cause insulin resistance IR despite its overall favorable influence on body fat composition IR is associated with special stores of fat in the muscle intramyocellular lipid or IMCL which can be measured by MRI The researchers hypothesize that changes in IR during GH treatment will be associated with a predictable but possibly contradictory change in muscle fat stores Girls receiving GH for short stature due to Turner syndrome or idiopathic short stature ISS will be studied both during and without GH treatment to assess the impact of GH treatment on muscle fat stores
Hypothesis Girls with Turner syndrome will have increased IMCL corresponding to their insulin resistance when compared to girls with ISS GH treatment may paradoxically reverse this association in girls with Turner syndrome
Objectives The objectives are to assess changes in IMCL during GH therapy and to increase the researchers knowledge of GH action
Study Design Prepubertal girls receiving GH therapy for short stature due to Turner syndrome or ISS will be recruited to participate in a crossover study Subjects will be studied twice first during GH treatment and at baseline following washout without GH for 3 months GH treatment for up to 6 months will be provided for eligible girls not currently receiving GH Assessments include
IMCL soleus and tibialis anterior measured non-invasively by proton magnetic resonance spectroscopy 1H-MRS
Body composition measured by DEXA and morphometry
Whole body insulin sensitivity assessed by oral glucose tolerance
Levels of plasma lipids and hormones
Endpoints The primary endpoint is to define the effect of GH on IMCL content in girls with Turner syndrome versus girls with ISS The secondary endpoint is to examine how GH affects IMCL content by identifying correlative changes in plasma hormones and metabolites
Significance This study is intended to find improved strategies for monitoring GH therapy In addition IMCL is anticipated to be a valuable probe for understanding GH effects on glucose homeostasis
Hypothesis Girls with Turner syndrome will have increased IMCL corresponding to their insulin resistance when compared to girls with ISS GH treatment may paradoxically reverse this association in girls with Turner syndrome
Objectives The objectives are to assess changes in IMCL during GH therapy and to increase the researchers knowledge of GH action
Study Design Prepubertal girls receiving GH therapy for short stature due to Turner syndrome or ISS will be recruited to participate in a crossover study Subjects will be studied twice first during GH treatment and at baseline following washout without GH for 3 months GH treatment for up to 6 months will be provided for eligible girls not currently receiving GH Assessments include
IMCL soleus and tibialis anterior measured non-invasively by proton magnetic resonance spectroscopy 1H-MRS
Body composition measured by DEXA and morphometry
Whole body insulin sensitivity assessed by oral glucose tolerance
Levels of plasma lipids and hormones
Endpoints The primary endpoint is to define the effect of GH on IMCL content in girls with Turner syndrome versus girls with ISS The secondary endpoint is to examine how GH affects IMCL content by identifying correlative changes in plasma hormones and metabolites
Significance This study is intended to find improved strategies for monitoring GH therapy In addition IMCL is anticipated to be a valuable probe for understanding GH effects on glucose homeostasis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| L3452n | None | None | None |